Effect of Pimecrolimus Cream on Cathelicidin Levels in Subjects With Eczema

NCT00946478 | Completed Results

• 1 other identifier: UCSDMED
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of topical pimecrolimus on the immune system by assessing the levels of antimicrobial peptides in the skin of patients with eczema. It is hypothesized that pimecrolimus applied topically will repair the body's immune system in patients with eczema by increasing antimicrobial peptides.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; elidel; pimecrolimus; CASM981; immunity; cathelicidin; antimicrobial peptide; eczema

Outcome Measures

Primary Outcomes (1)

• Cathelicidin mRNA Expression Levels in Adult Skin From Patients With AD

  Delta-delta CT values were measured using RT-PCR of cathelicidin mRNA in human biopsy samples at baseline, and then 3 weeks after treatment with either pimecrolimus or placebo

  3 weeks

Study Arms (2)

Pimecrolimus

ACTIVE COMPARATOR

Drug: Pimecrolimus

Vehicle cream

SHAM COMPARATOR

Other: Vehicle cream

Interventions

Pimecrolimus DRUG

20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. Lesional target site and non-lesional site will be determined at Visit 1. Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).

Also known as: Elidel, CASM 981

Pimecrolimus

Vehicle cream OTHER

20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. Lesional target site and non-lesional site will be determined at Visit 1. Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).

Vehicle cream

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years
• Target lesion IGA ≥2
• Target IGA=0 (for non-lesional site)
• Male or female of any race and ethnicity
• Chronic AD for more than one year duration
• Subject of child-bearing potential must be willing to practice effective birth control during the study
• Subject agrees to comply with study requirements and attend all required visits.

You may not qualify if:

• Patients ≥ 18 years of age with only AD of the face
• Women of childbearing potential not using the contraception method(s) specified in this study (abstinence, IUD, diaphragm, oral contraceptives)
• Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
• Hypersensitivity to pimecrolimus cream or any excipient of the cream
• Subject has a skin disorder in addition to dermatitis in the areas to be treated
• Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
• Pregnant or nursing females
• Immunocompromised patient (e.g., lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome), or with a history of active or malignant disease (excluding non-melanoma skin cancer)
• History of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
• Patients known to be non-compliant with a medication regimen
• Subjects with significant concurrent medical condition(s) at screening that in the view of the investigator prohibits participation in the study (e.g., severe concurrent allergic disease, condition associated with malignancy, and condition associated with immunosuppression)
• Active viral or fungal skin infections at the target areas
• Previous participation in this study
• Ongoing participation in another investigational trial
• Use of any oral or topical antibiotic during the study and up to one week prior to entering the study

Sponsors & Collaborators

• University of California, San Diego: lead
• Novartis: collaborator

Study Sites (1)

University of California, San Diego - Dept of Dermatology

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Tissa Hata
• Organization: UCSD Dermatology

ucsddermstudies@gmail.com

858-657-8390

Study Officials

• Richard Gallo, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair

Study Record Dates

• First Submitted: July 24, 2009
• First Posted: July 27, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 10, 2014
• Results First Posted: March 10, 2014

Record last verified: 2014-01

Locations

US (1)